Marrow Cellution Bone Marrow Aspiration Needle

K150563 · Ranfac, Corp. · KNW · May 22, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150563
• Device Name: Marrow Cellution Bone Marrow Aspiration Needle
• Applicant: Ranfac, Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

Device Story

Single-use, disposable bone marrow aspiration needle; used by medical professionals to access marrow cavity. Device consists of hollow outer cannula, hollow inner cannula with closed end and side ports, and 10ml syringe. Principle of operation involves boring into bone; inner cannula allows aspiration from sides rather than tip; enables needle retraction during aspiration to prevent sampling from previously aspirated areas. Output is aspirated bone marrow or autologous blood. Used in clinical settings; aids healthcare providers in obtaining marrow samples for diagnostic or therapeutic purposes.

Clinical Evidence

No clinical data. Substantial equivalence supported by design verification testing and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Materials: ABS handles, AISI 304 stainless steel cannula/stylet (tested per ISO 9626). Configuration: 11Ga needle, hollow outer cannula, hollow inner cannula with closed end and side ports. Sterilization: Ethylene Oxide. Mechanical device; no energy source or software.

Indications for Use

Indicated for aspiration of bone marrow or autologous blood in patients requiring such procedures, using a standard piston syringe.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Ranfac Aspiration Needle with Adjustable Guide (K140991)
• Ranfac Bone Marrow Aspiration Needle (K131157)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

Ranfac Corporation Mr. Christopher Whelan Senior Vice President 30 Doherty Avenue, P.O. Box 635 Avon, Massachusetts 02322

Re: K150563

Trade/Device Name: Marrow Cellution Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: March 4, 2015 Received: March 6, 2015

Dear Mr. Whelan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Traditional 510(k) - Marrow Cellution Bone Marrow Aspiration Needle

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| | See PRA Statement below. |

Indications for Use

| 510(k) Number ( <i>if known</i> ) | K150563 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Marrow Cellution Bone Marrow Aspiration Needle |
| Indications for Use (Describe) | The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. |

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

The contents of this 510(k) summary on the following pages have been provided in conformance with 21 CFR PP 807.92 "content and format of a 510(k) summary".

#### 1. Submitter/Sponsor

Ranfac Corp. 30 Doherty Avenue Avon, MA 02322 FDA Registration Number 1211566 Telephone Number/Fax: [phone] ext. 106/508-584-8588 Contact Person: Christopher P. Whelan Date Prepared: March 04, 2015

#### 2. Device Name

Trade Name: Marrow Cellution Bone Marrow Aspiration Needle Common or Usual Name: Aspiration Needle Classification Name: Gastroenterology-Urology-Biopsy Instrument 21 CFR §876.1075, Product Code KNW Classification: Class II

#### 3. Predicate Device:

| Trade Name | 510(k) | Company |
|------------------------------------------------|---------|--------------|
| Ranfac Aspiration Needle with Adjustable Guide | K140991 | Ranfac Corp. |
| Ranfac Bone Marrow Aspiration Needle | K131157 | Ranfac Corp. |

#### 4. Device Description

The Marrow Cellution Bone Marrow Aspiration Needle consists of a Ranfac Aspiration Needle with Adjustable Guide as well as an additional Aspirator Cannula and a 10ml Syringe.

The Marrow Cellution Bone Marrow Aspiration Needle is a single use disposable needle that allows the medical device professional the ability to aspirate from the sides of the needle without aspirating from the needle tip. This allows the needle to be retracted during aspiration ensuring aspirate will not be compromised by the end being open to an area that has already had aspirate removed.

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## 510(k) Summary

#### 5. Indications For Use

The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

#### Comparison of the Technological Characteristics With the Predicate Devices: 6.

As compared with the predicate devices, and as shown below, the Marrow Cellution Bone Marrow Aspiration Needle has the same indications for use, and has similar technological and operational characteristics when compared with the predicate devices.

### Table 5.1 Comparison of the Proposed Marrow Cellution Bone Marrow Aspiration Needle to the Ranfac Aspiration Needle with Adjustable Guide and Ranfac Bone Marrow Aspiration Needle

| | Marrow Cellution Bone<br>Marrow Aspiration Needle<br>(This Submission) | Ranfac Aspiration Needle<br>with Adjustable Guide<br>(K140991) | Ranfac Bone Marrow<br>Aspiration Needle<br>(K131157) |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | The Marrow Cellution Bone<br>Marrow Aspiration Needle is<br>intended for use for aspiration of<br>bone marrow or autologous blood<br>using a standard piston syringe. | The Ranfac Aspiration Needle<br>with Adjustable Guide is intended<br>for use for aspiration of bone<br>marrow or autologous blood using<br>a standard piston syringe. | The Ranfac Bone Marrow<br>Aspiration Needle is<br>intended for use in aspirating<br>bone marrow. |
| Design | Sterile, Disposable | Sterile, Disposable | Sterile, Disposable |
| Performance<br>Characteristics | Needle bores into bone to access<br>marrow cavity | Needle bores into bone to access<br>marrow cavity | Needle bores into bone to<br>access marrow cavity |
| Cannula<br>Configuration | Hollow Outer Cannula with cutting<br>edges without side ports<br>Hollow Inner Cannula with closed<br>end and side ports | Hollow Cannula with cutting<br>edges without side ports | Hollow Cannula with cutting<br>edges with or without side<br>ports |
| Stylet<br>Configuration | Trocar Tip and Blunt Tip | Trocar Tip and Blunt Tip | Trocar Tip |
| Ga. Size | 11Ga. | 11Ga. | 11Ga. & 8Ga. |
| Handle<br>Configuration | Handle is Molded to Cannula<br>Handle is Molded to Stylet | Handle is Molded to Cannula<br>Handle is Molded to Stylet | Handle is Molded to Cannula<br>Handle is Molded to Stylet |
| Materials:<br>Handles<br>Cannula/Stylet<br>Sterilization | ABS<br>AISI 304 Stainless Steel<br>(tested per ISO 9626)<br>Supplied Sterile<br>(Ethylene Oxide) | ABS<br>AISI 304 Stainless Steel<br>(tested per ISO 9626)<br>Supplied Sterile<br>(Ethylene Oxide) | ABS<br>AISI 304 Stainless Steel<br>(tested per ISO 9626)<br>Supplied Sterile<br>(Ethylene Oxide) |

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### 510(k) Summary

#### 7. Performance Data

Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Marrow Cellution Bone Marrow Aspiration Needle performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design verification test reports are included in Section 18.

Biocompatibility information is consistent with the requirements of ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and Testing, and therefore the materials used in the manufacture of the Marrow Cellution Bone Marrow Aspiration Needle are suitable for their intended use. Biocompatibility information is included in Section 15.

#### 8. Clinical Data

Not applicable.

#### 9. Conclusion

Based on the similarities in indications for use, materials, design, principles of function, biocompatibility and sterilization between the Marrow Cellution Bone Marrow Aspiration Needle, subject of this premarket notification, and the predicate devices, the proposed subject device has been shown to be substantially equivalent to the predicate devices in accordance with Section 510(k) of the Federal Food, Drug and Cosmetic Act.